Wireless heart pacemaker and defibrillator team up to stop dangerous rhythms

NCT ID NCT04798768

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests a new system that combines a leadless pacemaker with a subcutaneous defibrillator to treat dangerously fast heart rhythms. The devices communicate wirelessly to deliver pacing therapy without wires inside the heart. About 300 people at risk for ventricular tachycardia are enrolled to see if the system is safe and works well in different body positions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: EMPOWER modular pacing system and EMBLEM subcutaneous ICD
What this could lead to: If successful, this could offer a less invasive, wire-free way to treat dangerous heart rhythms and reduce the need for repeat procedures.
What could go wrong: This is an early-stage device trial with a moderate number of participants. The system may fail to communicate properly or cause complications like infection or device malfunction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

297 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient who meets Class I, IIa, or IIb guideline ICD indications\[i\],\[ii\], or who has an existing TV-ICD\[iii\] or S-ICD\[iv\] * Patient who is deemed to be at risk for MVT based on at least ONE of the following: * History of Non-Sustained MVT with LVEF ≤ 50% * History of sustained VT/VF (secondary prevention) with LVEF ≤ 50% or significant cardiac scar\* * History of syncope deemed to be arrhythmic in origin * History of ischemic cardiomyopathy with LVEF ≤35% * History of non-ischemic cardiomyopathy with LVEF ≤35% and significant scar\* * Patient who is willing and capable of providing informed consent (which is not to include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing associated with this investigation at an approved study site and at the intervals defined by this protocol * Patient who is age 18 years or above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: * Patient with an ongoing complication due to Cardiac Implantable Electronic Device (CIED) infection or CIED explant * Transvenous lead remnants within the heart from a previously implanted CIED (Note: transvenous lead remnants outside the heart (e.g., in the SVC) are allowed) * Patient with a known LA thrombus * Patient with a ventricular arrhythmia due to a reversible cause * Patient indicated for implantation of a dual chamber pacemaker or cardiac resynchronization therapy (CRT) * Patient with another implanted medical device that could interfere with implant of the leadless pacemaker, such as an implanted inferior vena cava filter or mechanical tricuspid heart valve * Patient requires rate-responsive pacing therapy * Patient is entirely pacemaker-dependent (defined as escape rhythm ≤ 30 bpm) * Patient with Acute Coronary Syndrome (i.e. Acute Myocardial Infarction, Unstable Angina) within 40 days * Inability to access femoral vein with a 21-French or larger inner diameter introducer sheath due to known anatomy condition, recent surgery, and/ or other relevant condition * Patient who has an active implanted electronic medical device intended for chronic use concomitantly with the study system, such as a left ventricular assist device (LVAD). Note that a temporary pacing wire is allowed. * Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA) * Patient with a known cardiovascular anatomy that precludes implant in the right ventricle * Patient with a known allergy to any system components * Patient with a known or suspected intolerance to S-ICD conversion testing, based on physician discretion * Patient is not likely to have meaningful survival\*\* for at least 12 months (documented or per investigator's discretion) * Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies/ registries needs prior written approval by BSC. Local mandatory governmental registries are accepted for co-enrollment without approval by BSC. * Patient who is a woman of childbearing potential who is known to be pregnant at the time of study enrollment (method of assessment upon investigator's discretion) \[i\]Al-Khatib, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. (2018); 138:e272-e391. \[ii\] 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). European Heart Journal (2015) 36, 2793-2867. \[iii\] TV-ICD system is expected to be fully explanted during or prior to full Coordinated System implant \[iv\] Potential subjects with a Model 1010 S-ICD Pulse Generator are only eligible for MODULAR ATP if they are getting upgraded to Model A209, A219 or future BSC S-ICD Pulse Generator; Patients with an existing S-ICD PG subject to the electrical overstress field action are only eligible for MODULAR ATP if they are getting a new BSC Model A209 or A219, or future BSC S-ICD Pulse Generator \*Significant cardiac scar is defined as a scar involving at least one ventricular myocardial segment (i.e., basal infero-septum) as identified in the official findings of a cMRI, or nuclear viability study, or echo report by the interpreting radiologist/ cardiologist who is not affiliated with the study \*\*meaningful survival means that a patient has a reasonable quality of life and functional status

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac cardiac rhythm disease ventricular fibrillation ventricular tachycardia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arrhythmia, ventricular Tachycardia, ventricular

Contacts and locations

Locations

AZ Osp Monaldi

Naples, 80131, Italy
AdventHealth Orlando

Orlando, Florida, 32803, United States
Amsterdam University Medical Center

Amsterdam, Netherlands
Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States
Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy
Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States
Baptist Health Lexington

Lexington, Kentucky, 40503, United States
CHRU de Lille

Lille, 59000, France
CHU Grenoble - Hospital Michallon

Grenoble, France
CHU de Nantes-Hopital Laennec

Nantes, France
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Cooper Hospital - University Medical Center

Camden, New Jersey, 08103, United States
Emory University Hospital

Atlanta, Georgia, 30308, United States
Erasmus MC University Medical Center

Rotterdam, 3015 CE, Netherlands
Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States
Hospital Clinic of Barcelona

Barcelona, 08036, Spain
Hospital European Georges-Pompidou

Paris, France
Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
Institut Universitaire de Cardilogie et Pnuemologie de Quebec (IUCPQ)

Québec, Canada
Institut de Cardiologie de Quebec (Montreal Heart)

Montreal, Quebec, H1T 1C8, Canada
Kepler Universitaetsklinikum

Linz, Austria
Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom
Manchester Heart Center

Manchester, M13 9WL, United Kingdom
Maria Cecilia Hospital SPA

Cotignola, Italy
Mayo Clinic

Rochester, Minnesota, 55905, United States
Mount Sinai Medical Center

New York, New York, 10029, United States
Na Homolce Hospital

Prague, Czechia
Northwell University Hospital

Manhasset, New York, 11030, United States
Ohio Health Research Institute

Columbus, Ohio, 43214, United States
Ohio State University Medical Center

Columbus, Ohio, 43210, United States
Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States
Scottsdale Healthcare - Shea

Scottsdale, Arizona, 84258, United States
Sentara Norfolk General

Norfolk, Virginia, 23507, United States
Southampton University Hospital

Southampton, United Kingdom
Spedali Civil di Brescia

Brescia, Italy
St. Antonius Ziekenhuis

Nieuwegein, Netherlands
The General Infirmary

Leeds, LS1 EX, United Kingdom
University of Washington Medical Center

Seattle, Washington, 98195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.